19 results
·
25ms
·
Sources: EU EUDAMED, US FDA
COOPERSURGICAL MALLEABLE SYTLET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SARSTEDT NEEDLE PROTECTOR
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO: STACKABLE CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IMPLANTABLE COLLAMER LENS (ICL)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·April 5, 2018
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·March 27, 2013
TOTAL ASR ACET IMP SIZE 50
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·March 2, 2011
THERMOPAD
FDA Adverse Event
Injury
·ANGIODYNAMICS, INC.·Product code GEI·April 2, 2008
MERSILENE TAPE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·November 20, 2025
VALIANT CAPTIVIA UNK
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 13, 2023
VALIANT CAPTIVIA UNK
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·July 13, 2023
VALIANT CAPTIVIA UNK
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·July 13, 2023
HOSP SS FLEXX METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 12, 2011
HOSP SS FLEXX METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 12, 2011
HOSP SS FLEXX METER LASER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·June 17, 2011
HOSP SS FLEXX METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 12, 2011
UNSPECIFIED BD SECONDARY EXTENSION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·September 24, 2022
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024